Positioning Biologics in Ulcerative Colitis

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1 Positioning Biologics in Ulcerative Colitis Bruce E. Sands, MD, MS Acting Chief, Gastrointestinal Unit Massachusetts General Hospital Associate Professor of Medicine Harvard Medical School Sequential Therapies for UC Disease Severity at Presentation Severe Moderate Anti-TNF Antibody Surgery CyA Salvage CyA Alternative Cyclosporine Thiopurine Steroid Steroid Resistance Alternative Thiopurine Corticosteroid Thiopurine Failure Primary Induction Mild Aminosalicylate Aminosalicylate Induction Maintenance Step-Up according to severity at presentation or failure at prior step 1

2 Possible Positioning of Biologics in UC Thiopurine failure Steroid resistance Steroid alternative Cyclosporine alternative Cyclosporine salvage Primary induction Possible Positioning of Biologics in UC Thiopurine failure Steroid resistance Steroid alternative Cyclosporine alternative Cyclosporine salvage Primary induction 2

3 Estimate of Efficacy of AZA for Treatment Success in UC Patients: Meta-Analysis Pooled RR Estimate Across 5 Trials Study Risk ratio (95% CI) % Weight Ardizzone 06 Sood 02 Sood 03 Sood 00 Jewell 1974 Overall (95% CI) 2.71 (1.30, 5.65) (0.96, 3.07) ( 0.31, 1.50) (0.71, 1.58) (0.89, 3.54) (0.93, 2.17) Risk ratio Leung Y et al. Dig Dis Sci. 08;53:1455. ACT 1 & 2 Baseline Characteristics ACT 1 ACT 2 Placebo 5 mg/kg 10 mg/kg Placebo 5 mg/kg 10 mg/kg (N=121) (N=121) (N=122) (N=123) (N=121) (N=1) Duration of disease yr 6.2± ± ± ± ± ±5.8 Mayo score 8.4± ± ± ± ± ±1.6 Concomitant medication no. (%) Corticosteroids 79 (65.3) 70 (57.9) 73 (59.8) 60 (48.8) 60 (49.6) 66 (55.0) mg/day 54 (44.6) 45 (37.2) 46 (37.7) 43 (35.0) 40 (33.1) 47 (39.2) 5-Aminosalicylates 85 (70.2) 82 (67.8) 86 (70.5) 89 (72.4) 92 (76.0) 91 (75.8) Immunosuppressants 53 (43.8) 66 (54.5) 59 (48.4) 54 (43.9) 52 (43.0) 50 (41.7) Corticosteroid-refractory disease 38 (31.4) 36 (29.8) 38 (31.1) 36 (29.3) 35 (28.9) 34 (28.3) 3

4 ACT 1 & 2 Baseline Characteristics ACT 1 ACT 2 Placebo 5 mg/kg 10 mg/kg Placebo 5 mg/kg 10 mg/kg (N=121) (N=121) (N=122) (N=123) (N=121) (N=1) Duration of disease yr 6.2± ± ± ± ± ±5.8 Mayo score 8.4± ± ± ± ± ±1.6 Concomitant medication no. (%) Corticosteroids 79 (65.3) 70 (57.9) 73 (59.8) 60 (48.8) 60 (49.6) 66 (55.0) mg/day 54 (44.6) 45 (37.2) 46 (37.7) 43 (35.0) 40 (33.1) 47 (39.2) 5-Aminosalicylates 85 (70.2) 82 (67.8) 86 (70.5) 89 (72.4) 92 (76.0) 91 (75.8) Immunosuppressants 53 (43.8) 66 (54.5) 59 (48.4) 54 (43.9) 52 (43.0) 50 (41.7) Corticosteroid-refractory disease 38 (31.4) 36 (29.8) 38 (31.1) 36 (29.3) 35 (28.9) 34 (28.3) Infliximab in Patients With Ulcerative Colitis: Clinical Response ACT 1 ACT 2 Placebo IFX 5 mg/kg IFX 10 mg/kg Patients (%) weeks 30 weeks 54 weeks Patients (%) weeks 30 weeks P<0.001 vs placebo P vs placebo Rutgeerts P et al. N Engl J Med. 05;353:

5 Infliximab in Patients with Ulcerative Colitis: Clinical Remission ACT 1 ACT 2 Placebo IFX 5 mg/kg IFX 10 mg/kg Patients (%) weeks 30 weeks 54 weeks 8 weeks 30 weeks Patients (%) P<0.001 vs placebo P vs placebo Rutgeerts P et al. N Engl J Med. 05;353:2462. Possible Positioning of Biologics in UC Thiopurine failure Steroid resistance Steroid alternative Cyclosporine alternative Cyclosporine salvage Primary induction 5

6 ACT 1 & 2 Baseline Characteristics ACT 1 ACT 2 Placebo 5 mg/kg 10 mg/kg Placebo 5 mg/kg 10 mg/kg (N=121) (N=121) (N=122) (N=123) (N=121) (N=1) Duration of disease yr 6.2± ± ± ± ± ±5.8 Mayo score 8.4± ± ± ± ± ±1.6 Concomitant medication no. (%) Corticosteroids 79 (65.3) 70 (57.9) 73 (59.8) 60 (48.8) 60 (49.6) 66 (55.0) mg/day 54 (44.6) 45 (37.2) 46 (37.7) 43 (35.0) 40 (33.1) 47 (39.2) 5-Aminosalicylates 85 (70.2) 82 (67.8) 86 (70.5) 89 (72.4) 92 (76.0) 91 (75.8) Immunosuppressants 53 (43.8) 66 (54.5) 59 (48.4) 54 (43.9) 52 (43.0) 50 (41.7) Corticosteroid-refractory disease 38 (31.4) 36 (29.8) 38 (31.1) 36 (29.3) 35 (28.9) 34 (28.3) ACT 1 & 2 Baseline Characteristics ACT 1 ACT 2 Placebo 5 mg/kg 10 mg/kg Placebo 5 mg/kg 10 mg/kg (N=121) (N=121) (N=122) (N=123) (N=121) (N=1) Duration of disease yr 6.2± ± ± ± ± ±5.8 Mayo score 8.4± ± ± ± ± ±1.6 Concomitant medication no. (%) Corticosteroids 79 (65.3) 70 (57.9) 73 (59.8) 60 (48.8) 60 (49.6) 66 (55.0) mg/day 54 (44.6) 45 (37.2) 46 (37.7) 43 (35.0) 40 (33.1) 47 (39.2) 5-Aminosalicylates 85 (70.2) 82 (67.8) 86 (70.5) 89 (72.4) 92 (76.0) 91 (75.8) Immunosuppressants 53 (43.8) 66 (54.5) 59 (48.4) 54 (43.9) 52 (43.0) 50 (41.7) Corticosteroid-refractory disease 38 (31.4) 36 (29.8) 38 (31.1) 36 (29.3) 35 (28.9) 34 (28.3) 6

7 Corticosteroid Refractory ACT 1 & 2 Response Rate, Corticosteroid Refractory vs. Not Corticosteroid Refractory 100% 90% 80% 70% 60% 50% 40% 30% % 10% 0% 35% ACT 1 ACT 2 77% 68% Placebo 5 mg/kg 10 mg/kg 100% 90% 80% 70% 60% 50% 40% 30% % 10% 0% 38% 63% 66% Placebo 5 mg/kg 10 mg/kg Not Corticosteroid Refractory 100% 90% 80% 70% 60% 50% 40% 30% % 10% 0% 67% 59% 38% Placebo 5 mg/kg 10 mg/kg 100% 90% 80% 70% 60% 50% 40% 30% % 10% 0% 65% 70% 26% Placebo 5 mg/kg 10 mg/kg Rutgeerts P et al. N Engl J Med. 05;353:2462. ACT 1 & 2 Clinical Remission and Off Steroids Clinical Remission and Off Steroids 35% 30% 25% % 15% 10% 5% 0% 24% 18% 26% 27% 19% 16% 10% 9% 3% Placebo 5 mg/kg 10 mg/kg ACT 1 Wk 30 ACT 2 Wk 30 ACT 1 Wk 54 P value <0.05 Rutgeerts P et al. N Engl J Med.. 05;353:

8 Possible Positioning of Biologics in UC Thiopurine failure Steroid resistance Steroid alternative Cyclosporine alternative Cyclosporine salvage Primary induction Infliximab vs. Steroids for Severe Ulcerative Colitis in the Hospital Setting Study Ochsenkuhn 04 Armuzzi 04 N 13 Infliximab dose 5 mg/kg 3 5 mg/kg 3 Response Outcome measure Infliximab Steroid Lichtiger score 5 to <10 at 3 83% 86% and 13 weeks Sutherland score 100% 100% 2 at 2 weeks Ochsenkuhn T et al. Eur J Gastroenterol Hepatol. 04;16:1167. Armuzzi A et al. Eur Rev Med Pharmacol Sci. 04;8:231. 8

9 Possible Positioning of Biologics in UC Thiopurine failure Steroid resistance Steroid alternative Cyclosporine alternative Cyclosporine salvage Primary induction Meta-analysis of intravenous corticosteroids in severe ulcerative colitis Cohort studies and controlled trials published between that reported the short-term colectomy rate in severe UC or reported variables that could predict treatment failure 581 of 1991 patients required colectomy (weighted mean 27% [95% CI, 26% 28%]) 28%]) 22 died (1% mortality rate; 95% CI, 0.7% 1.5%) No dose-colectomy response of methylprednisolone therapy beyond 60 mg daily (R2 <0.01, P =0.98) Predictors of medical failure: disease extent, stool frequency, temperature, heart rate, C-reactive protein, albumin, and radiologic assessment. Turner D, et al. Clin Gastroenterol Hepatol.. 07;5:

10 Cyclosporine for Severe Ulcerative Colitis in the Hospital Setting Study N CyA dose Lichtiger 1994 D Haens 01 Van Assche mg/kg IV 4 mg/kg IV 4 or 2 mg/kg IV Outcome measure Lichtiger score to <10 for 2 days Lichtiger score 3 to <10 on days 7 and 8 Lichtiger score 3 to <10 on day 8 Response CyA 4 mg/kg Placebo Steroids CyA 2 mg/kg 82% 0% 64% 84% 53% 86% Lichtiger S et al. N Engl J Med. 1994;330:1841. D Haens G et al. Gastroenterology. 01;1:1323. Van Assche G et al. Gastroenterology. 04;125:1025. Meta-analysis of intravenous corticosteroids in severe ulcerative colitis Cyclosporine was used in only 100 patients, with a 51% (95% CI, 41% 60%) short-term success rate Turner D, et al. Clin Gastroenterol Hepatol.. 07;5:

11 Serious Infections and Death From High-Dose IV Cyclosporine for IBD Mt. Sinai 111 patients (2 deaths, 1.8%) Pneumocystsis carinii, 1 patient Septic shock, 1 patient University of Chicago 74 patients (1 death, 1.4%) Pneumocystis carinii, 1 patient University of Leuven 142 patients (4 deaths, 2.8%) Pneumocystsis carinii, 1 patient Systemic aspergillosis, 2 patients CML, 1 patient Sternthal MB et al. Am J Gastroenterol. 08;103:937. Stein R et al. Gastroenterology. 1997;112:A1096. Moskovitz DN et al. Clin Gastroenterol Hepatol;4:760. Infliximab for Severe Ulcerative Colitis in the Hospital Setting Study Sands 01 Jarnerot 05 N Infliximab dose 5, 10, mg/kg 1 5 mg/kg 1 Outcome measure Lichtiger score 5 to <10 at 2 weeks No colectomy at 90 days Response Infliximab Placebo 50% 0% 71% 33% Sands BE et al. Inflamm Bowel Dis. 01;7:83. Jarnerot G et al. Gastroenterology. 05;128:

12 Infliximab for severe, steroid refractory UC: Two year follow-up of colectomy rate Probability not operated IFX n=24 Placebo n=21 46% p<0.05 (logrank test) 76% Time (months) Pts at risk, n IFX Pbo Cyclosporine: 30 43% Cohen 1999 Moskovitz 06 Campbell 05 IFX group 13/15 initial responders started on AZA vs 3/7 in placebo group Only 4/24 received more than one IFX infusion Gustavsson A, et al. Gastroenterology 07;132(4 Suppl 2):A146-7 Infliximab for ulcerative colitis: Long-term outcomes Retrospective cohort of 30 pts treated at Oxford from Sixteen (53%) came to colectomy a median of 140 days after their first infusion (range 4-607) No difference in colectomy between those receiving infliximab for acute severe ulcerative colitis failing intravenous steroids (8/14) and outpatients with steroid-refractory ulcerative colitis (8/16) Only 17% (5/30) achieved a steroid-free remission after a median follow-up of 13 months (range 2-72). Jakobovits SL, et al. Aliment Pharmacol Ther.. 07;25:

13 Infliximab as rescue therapy in acute severe UC Inclusion criteria: Hospitalization for acute UC, failure to respond to IV steroids, IFX therapy during acute admission Results (N=39 patients): 26/39 (66.6%) patients avoided urgent colectomy at hospital discharge 17/24 initial responders off steroids at 90d 1 death (Pseudomonas aeruginosa) Serum albumin but not CRP or stool frequency predicted response to IFX (Pts with albumin <34g/L on d3 more likely to undergo colectomy) Influence of IFX on colectomy Percent without colecomty Patient lost to follow-up Patient died of bronchopulmonary pneumonia Days post-infliximab Albumin levels and response to IFX Albumin g/l 40 Responders Non-responders Lees CW, et al. DDW 07: S1136 Colectomy rates after infliximab for refractory UC (Leuven) N=130 from January 00 October 06 62% extensive 47% Mayo score 3 31% received induction 43% complete short term response % partial short term response 37% did not respond 18% required colectomy in 2.5 years of follow up Ferrante M et al. DDW 07. #960 13

14 Impact of Infliximab on Post-Surgical Complications in UC Author (year) Diagnosis N (IFX) N (non-ifx) Increase in complications (yes/no) Schluender 07 UC no Selvasekar 07 UC yes Mor 08 UC yes Mor et al, Dis Colon Rectum 08 Selvasekar et al, J Am Coll Surg 07 Anastomotic Leak Rates: UC Center Infliximab Noninfliximab Cleveland Clinic 17.4% 2% Mayo Clinic 9% 2% MGH 3% 2.9% 14

15 Risk Factors for Mortality With Colectomy for UC Nationwide Inpatient Sample ( ) 6502 discharges for UC patients who underwent a total abdominal colectomy Postoperative mortality: 2.3% Emergently admitted patients whose surgery was performed after 11 days in hospital were at higher risk of Death: aor 3.18 ( ) Complications: aor 1.42 ( ) Kaplan GG et al. Gastroenterology. 08;134:680. Possible Positioning of Biologics in UC Thiopurine failure Steroid resistance Steroid alternative Cyclosporine alternative Cyclosporine salvage Primary induction 15

16 Cyclosporine (CSA) and IFX as acute salvage therapies for each other in severe steroid refractory UC Salvage information CSA first IFX first (n-9) (n=10) Avg IFX infusions Avg CSA duration 3 months 6.2 months Avg interval between drugs 17 days (range 1 30) 21 days (range 3 31) Concomitant use of 77% (7/9) 66% (6/9) IMM Colectomy within 1 y 33.3% (3/10) 44.4% (4/9) Maser EA et al. DDW 07. S1132 Cyclosporine (CSA) and IFX as acute salvage therapies for each other in severe steroid refractory UC Patients (%) Remission CSA-first Response 33 IFX-first SAEs total = 16% (3/19) Death gram ve sepsis Pancreatitis Enterococcus, and Klebsiella bacteremia Herpes esophagitis Other immune suppression Drug sequence Medical interval AZA CSA-first 1 day AZA Prednisone taper IFX-first 4 weeks IFX-first The likelihood of achieving steroid-free remission, in severe steroid-refractory UC patients who fail CSA or IFX, is low and similar despite which drug is used first Incidence of a SAE of 13%, including 1 fatality, suggest the risks outweigh the benefit of acute salvage therapy Maser EA et al. DDW 07. S days 16

17 Successive treatment with cyclosporine and infliximab in severe ulcerative colitis Eligible n=94 Included n=86 Not included n=8 CYS à IFX > 1 mo (n = 5) IFX à CYS > 2 mo (n = 2) Crohn s (n=1) CYS-IFX n =65 (76%) IFX-CYS n = 21(24%) Colectomy within 3 mo n=26 (40%) Colectomy within 3 mo n=7 (33%) M3 n=39 (60%) n=14 (67%) Lost to follow up n=6 Lost to follow up n=3 Colectomy 3-12 mo n=9 (14%) Colectomy 3-12 mo n=6 (29%) M12 n=24 (37%) Leblanc S, et al. DDW 09. #561. n=5 (24%) pts lost to follow up were counted as failures Successive treatment with cyclosporine and infliximab in severe ulcerative colitis Adverse Events N CIS- IFX (n=65) IFX- CIS (n=21) Steroids (n=74) AZA/ MP (n=63) Non op. (n=37) Before surgery (n=49) After surgery (n=49) Death Infection Renal Hepatic SB obstruction Cardiac Pulmonary Rash Total events Pts % Pts % % % 26 27% % % % % Leblanc S, et al. DDW 09. # postoperative death due to thromboembolism in a 40 year-old man 2 n=4, n=3 and n=1 were related to cyclosporine, respectively 17

18 Possible Positioning of Biologics in UC Thiopurine failure Steroid resistance Steroid alternative Cyclosporine alternative Cyclosporine salvage Primary induction ACT 1 & 2: Mucosal Healing Proportion of Patients (%) p< Endoscopic Subscore of 0 or Week 8 Week Placebo 5 mg/kg Infliximab 10 mg/kg Infliximab Rutgeerts P et al. N Engl J Med.. 05;353:

19 ACT 1 & 2: Endoscopy Subscore of 0 Proportion of Patients (%) p< Week 8 Week 30 Placebo 5 mg/kg Infliximab 10 mg/kg Infliximab Rutgeerts P et al. N Engl J Med.. 05;353:2462. ACT 1& 2 Clinical Remission at Week 30 by Mucosal Healing Status at Week 8 Percent of Patients Achieving Clinical Remission (%) Mucosal Healing at Week 8 No Mucosal Healing at Week 8 Rutgeerts P et al. N Engl J Med.. 05;353:

20 Possible Positioning of Biologics in UC Thiopurine failure: Yes Steroid resistance: Yes Steroid alternative: Insufficient evidence Cyclosporine alternative: Yes;?increased risk for surgical complications Cyclosporine salvage: Probably not Primary induction: No evidence

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